Healthy Skepticism Library item: 1535

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Some Consumer Ads for Aventis' Taxotere Misleading, U.S. FDA Charges
Reuters 2003 Dec 12

Full text:

U.S. regulators told drugmaker Aventis to stop circulating misleading ads about a cancer drug and to take steps to correct false impressions consumers may have received, according to a letter made public on Thursday.

Aventis overstated the survival benefits of cancer drug Taxotere and minimized serious risks in magazine advertisements aimed at consumers, the Food and Drug Administration said in a warning letter to the company dated Nov. 12. The letter was made public on the FDA Web site on Thursday.

Aventis spokeswoman Lisa Kennedy said the company was “working with the FDA to clarify any issues that they have.”

Taxotere is approved for treating certain types of breast cancer and lung cancer.

The FDA said some Taxotere promotions it reviewed “imply to patients that if they do not add Taxotere to their treatment, they will not survive.”

“This is misleading, given that there are other treatments available for breast cancer and lung cancer with proven survival benefits,” the FDA’s letter said.

The ads also omitted important information about potential side effects, including the possibility of life-threatening infections and severe allergic reactions, the FDA said.

The agency previously objected to physician-directed promotions for Taxotere that made misleading claims and left out important safety information, the FDA’s letter said.

“We are concerned that you continued to promote Taxotere in a similar manner to consumers in popular consumer magazines,” the FDA said, noting that two of the ads ran in the entertainment magazine People.

The agency told Aventis to immediately stop disseminating the consumer-directed ads at issue and any similar ones and to provide a plan “to disseminate accurate and complete information to the audience(s) that received the violative promotional materials.”

“We are continuing to evaluate other aspects of your promotional campaign for Taxotere, and may determine that additional measures will be necessary to fully correct the false and misleading messages resulting from your violative conduct,” the FDA letter said.